Sometimes Developing Patient-Empowering Technologies Means Ignoring What Doctors Say

The device industry has long had close ties to physicians, who have served as consultants helping to develop products. Physician/Surgeon need has long shaped what the device industry makes.

But sometimes developing the next-generation minimally invasive technologies that can help patients necessarily mean that you distance yourself from surgeons and their opinions.

At least that has been the experience of Stanton Rowe, corporate vice president, advanced technology and chief scientific officer at Edwards Lifesciences who came to the California device maker through its acquisition of Percutaneous Valve Technologies. Percutaneous Valve Technologies developed the transcathetier aortic valve replacement device that ultimately won FDA approval under Edwards in November 2011. Transcatheter aortic valve replacement has been heralded as a minimally invasive alternative for patients whose heart valves need replacement because of severe aortic stenosis but who are too sick to undergo open heart surgery.

In a recent interview with MD+DI, Rowe, who was CEO at Percutaneous Valve Technologies, recalled that both Edwards and PVT had parallel programs developing a TAVR device.

But Edwards was a little too close to cardiac surgeons who told them a different story about the potential for a TAVR device.

“Edwards had modest expectations for this technology because surgeons stated that there was a very small number of patients who were refused surgery.” Rowe said.

In other words, surgeons were telling Edwards that there was really not much of a business opportunity in a TAVR device.

Rowe and others at Percutaneous Valve Technologies chose to distance themselves from surgeons and find evidence of a larger need elsewhere. That came from cardiologists who were performing balloon valvuloplasty, a predicate procedure to TAVR, on patients who “came out of the woodwork” for this procedure because they had been denied open heart surgery, Rowe said.

“They meant to tell us that many more nonsurgical patients were encountered than they ever predicted,” Rowe recalled. "Later, we were able to turn to hard evidence [through] diagnostic echocardiograms that confirmed the presence of aortic stenosis, to determine that there was a large group of patients who were diagnosed with severe aortic stenosis, yet they were not getting surgery for a variety of reasons."

Rowe and others found that a whopping 40% were not getting surgery, a much larger percentage than previously expected, Rowe said.

“We were confident that if they had a less-invasive treatment option like transcatheter valve replacement, more patients who were suffering from this debilitating and deadly disease could be treated,” Rowe explained.

When Percutaneous Valve Technologies performed the first-in-man implant in 2002, Edwards’ interest was piqued, Rowe said. It ended up announcing its intent to buy Percutaneous Valve Technologies for $125 million in late 2003.

Rowe will be speaking about patient empowering technologies at the MD&M Executive Summit, at the Anaheim Marriott in Anaheim, California on Feb. 10.

Meanwhile, Edwards is gearing up for competition with Medtronic, whose competing CoreValve TAVR device recently won FDA approval. The company has suffered some bumps in its rollout of the Sapien transcatheter aortic valve replacement device where sales have not met projections since the Nov. 2011 approval in the U.S. Yet, two years later, patients who are at severe risk of undergoing open heart surgery as well as those who are at moderate risk, have been helped by Edwards’s TAVR device.

And now the company is on the cusp of an approval of its Sapien XT valve in the U.S., which is smaller in size than the original Sapien heart valve, in the U.S. Analysts feel that with the introduction of the Sapien XT, Edwards will likely win back some share it loses to Medtronic and its CoreValve system.

-- By Arundhati Parmar, Senior Editor, MD+DI
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